The invention relates to the electrophysiology of the human body. More specifically, the invention provides methods of altering normal charge distribution within selected areas of the body to increase the effectiveness of bioactive agents such as drugs in these areas.
Modern medical practice includes the application of electromotive force, defined by the Handbook of Chemistry and Physics, 39th Edition, as xe2x80x9cthat which causes a flow of currentxe2x80x9d, to the body in several beneficial techniques. For example, pharmacological agents are delivered to, or released at, target sites within the body through the use of current flow, either between electrodes or induced by oscillating or pulsing electric or magnetic fields which alternately push and pull electrons within the body structure. Balkiston""s Gould Medical Dictionary (McGraw-Hill) defines these techniques as:
Iontophoresis: a method of inducing therapeutic particles into skin or other tissue by means of electric current.
Electrophoresis: the migration of charged colloidal particles through the medium in which they are disbursed when placed under the influence of an applied electric potential.
Electroosmosis: the movement of a conducting liquid through a permeable membrane under the influence of a potential gradient, thought to be caused by the opposite electrification of the membrane and liquid.
U.S. Pat. Nos. 4,141,359 and 5,336,168 show representative methods of these technologies.
In another medical use of electromotive force, direct or induced current flow is used to promote bone healing. U.S. Pat. Nos. 4,683,873 and 4,993,413 show representative methods of this technology.
In still another medical use of electromotive force, direct or induced current flow is used for xe2x80x9celectrostimulationxe2x80x9d of nerves to mask pain. U.S. Pat. Nos. 5,342,410 and 5,397,338 show representative methods of this technology.
The foregoing uses of electromotive force in medicine all involve a flow of current, or continuous movement of charge carriers (i.e., electrons or ions) through a conductive medium under the influence of an electric field that is maintained in the medium by contact with a power source. Unless an electric field within a conductor is maintained by a power source, however, the field and thus also the current will drop to zero regardless of the field outside the conductor. This is a well known and accepted tenet of basic physics. In regard to conductive biological systems, some researchers in the field have predicted, on a theoretical level, that an external electric field with no conductive connection to the body is reduced to such a degree inward of the surface of a human body that it has been commonly believed that an external electric field alone could have little effect inside the body. For example, one researcher has used Maxwell""s equations with certain boundary conditions to mathematically predict that a static electric field passing inside a living organism is rendered one trillion times smaller inside the organism than the same field outside the organism. Also, the same equations have been employed to support a prediction that the electric field portion of a 60 Hertz electromagnetic field is rendered 40 billion times smaller inside a living organism than the same field outside the organism (CRC Handbook of Biological Effects of Electromagnetic Fields, CRC Press, pages 5-9, 1986).
As a result of this common belief concerning abrupt reduction of an external electric field at the surface of a living organism, the question of whether such a field may have biological effects on living organisms has received little attention.
A magnetic field, on the other hand, is able to penetrate into a conductor. Unlike external electric fields, magnetic fields have a role in the modern practice of medicine. For example, large magnets are used in nuclear magnetic resonance imaging systems.
A magnetic field can have biological consequences. Researchers have reported that a magnetic field can alter the growth of bacteria and yeasts. Researchers have also reported that a magnetic field can alter enzyme activity in vitro, particularly if the field is non-uniform. Furthermore, researchers have reported that a magnetic field reduces the ability of protozoa to survive exposure to a toxic substance. See the CRC Handbook of Biological Effects of Electromagnetic Fields, supra, at pages 173-175.
The prior art does not contemplate the use of static electric or static magnetic fields to increase the effectiveness of bioactive agents by altering the receptivity or susceptibility of cells, or other therapeutic targets such as bacteria or viruses for example, to such agents. These methods form the basis of the invention.
It is now recognized that every action in every living organism, including the human body, results from electric charges and their attendant electric fields. Each of the approximately seventy-five trillion cells in a human body utilizes specific patterns of electric charges to create specific patterns and strengths of electric fields on, within, and around the cell membranes and interior components to carry out the various processes required to maintain life. Abnormal charge distributions can lead to an inability to properly carry out normal processes and result in maladies ranging from aches and pains to serious disease. Such maladies, and even a genetic susceptibility to such maladies, shall be referred to herein as xe2x80x9cdisease conditionsxe2x80x9d.
The drugs and other bioactive agents that are administered to treat such maladies have molecules with a specific electron arrangement which provides a specific electric field. Organic materials such as cells in the human body likewise have chemical constituents with specific electron and electric field arrangements, as do pathogens and toxins. The reason a particular bioactive agent is effective in treating a particular disease is generally that the specific electron and electric field arrangement exhibited by the bioactive agent interacts, in a complimentary fashion, with the specific electron and electric field arrangement exhibited by a site on a therapeutic target, such as human cells, enzymes, bacteria, and so forth. This interaction alters the nature of the target in a manner that is beneficial to the patient. For example, a bioactive agent may have an electrical configuration which interacts with that at some location of a human cell to cause the agent to accumulate near, or attach to, a specific receptor on or in the cell. This, at least temporarily, beneficially alters the cell, or the cell""s operation, or aids the cell in carrying out normal processes. This dependence on specific electron and field strength patterns is the reason bioactive agents are effective against some maladies and not others. This is also the reason some agents are only marginally effective, i.e., the electron pattern and resulting field strength of the agent""s molecules are not quite right for optimum attraction of, and connection with, a therapeutic target giving the desired result. It is almost universally desirable to increase the effectiveness, or increase the range of effects, of the bioactive agents in the medical pharmacopoeia.
The inventor has discovered that exposing the body, or specific desired areas of the body, to a static electric field or to a static magnetic field can significantly increase the effect of some bioactive agents on the body. Presumably these fields act to slightly alter or strengthen the electric charge distribution pattern near, on, or within the exposed body cells, and thus increase the receptivity or susceptibility of the cells to reaction with the bioactive agent. Also, there is reason to believe that using static electric or static magnetic force fields to alter the normal electric charge distribution near, on, or within the exposed cells may in addition cause the cells to prematurely initiate some of their normal metabolic operations and thus place them in a condition which increases their receptivity or susceptibility to applied bioactive agents.
The term xe2x80x9cstatic electric fieldxe2x80x9d as used herein is intended to mean fields from an electrical potential which maintain the same polarity over a period of time of at least 1 second, but more commonly over minutes or hours. The term xe2x80x9cstatic magnetic fieldxe2x80x9d as used herein is intended to mean fields from a magnetic element which maintain the same polarity over a period of time of at least 1 second, but more commonly over minutes or hours.
Static electric and static magnetic fields will occasionally be referred to collectively herein as xe2x80x9cpolarizing fields.xe2x80x9d This nomenclature is believed to be appropriate since a nonpolar particle such as a molecule in an electric field may become polarized by induction, and the dipole moment or degree of polarization of an inherently polarized particle is modified by a static electric field. The mere presence of a static magnetic field does not induce or modify polarization, but a static magnetic field is nevertheless appropriately characterized as a polarizing field in the context of the invention since the degree of polarization of an inherently polarized particle which moves with respect to a magnetic field is modified by the magnetic field. For a living body, such movement is to be expected.
According to the invention, a bioactive agent is administered to a patient and the patient""s body or a target region thereof is exposed to a polarizing field without producing current flow or heat, as would occur if the patient""s body were made to be part of an electric circuit, or exposed to moving magnetic fields, as in the prior art. Instead, the polarizing field is applied to achieve a polarizing effect within the tissue, creating dipoles from particles such as atoms, ions, or molecules in, on, or near the components of the tissue, or modifying the charge distribution of such particles if they are inherently polarized, to achieve enhanced reaction with a desired bioactive agent. Depending on the components of the tissue, the polarizing field applied, and the bioactive agent, the individual components and/or bioactive agent may be influenced in a number of ways, for example they may:
shift their electron distribution to favor reaction.
shift their electron distribution to create charge gradients favoring attraction of, and reaction between, the components and bioactive agents.
rotate to expose a surface favoring reaction.
move to a location (within the cell membrane for example) favoring reaction.
prematurely initiate a normal activity or process of the cells or other components which favors reaction with the desired bioactive agent.
A polarizing field is applied with the polarizing force in one direction long enough to achieve any, or any combination of, the above actions. Typically the polarizing force direction of the applied field will be maintained for at least numbers of seconds, but most often for numbers of minutes or hours, or continuously, during the treatment period. The force direction may also be periodically changed to provide additional opportunities for cellular reaction.
The steps in using the invention may vary to meet the requirements of specific bioactive agents, or specific locations of a patient""s body. Most often, the steps will include:
1. Administering the desired bioactive agent or agents to the patient through any medically approved route.
2. While the agent is present in the body (even as the agent is being administered, if desired) exposing at least a target region of the body to a polarizing field.
3. Continuing the polarizing field exposure for a length of time based on the active life of the bioactive agent, or at least a portion of the active life, such as half-life, for example.
4. Discontinuing the exposure to the polarizing field after the desired effect has occurred, or at a point based on the active life of the bioactive agent.
It is an object of the invention to increase the effectiveness of a bioactive agent or agents administered to the body by exposing the whole body, or a selected target region of the body, to a nonuniform, or to a relatively uniform, polarizing static electric and/or static magnetic field.
Another object of the invention is to increase the effectiveness of a bioactive agent or agents administered to the body by exposing all of the body, or a selected target region of the body, to a nonuniform, or to a relatively uniform, polarizing static electric and/or static magnetic field long enough to influence charge distribution near, on, or within the exposed cells to increase the receptivity or susceptibility of the cells to interaction with the bioactive agent by increasing attraction of the agent to locations on and/or in the cells, and/or by initiating or preventing a metabolic process of the cells in the presence of the agent.
Another object of the invention is to increase the effectiveness of a bioactive agent or agents administered to the body by exposing all of the body, or a selected target region of the body, to a nonuniform, or to a relatively uniform, polarizing static electric and/or static magnetic field, long enough to influence charge distribution near, on, or within exposed cells to increase the receptivity or susceptibility, or initiate or prevent metabolic processes, of the cells so as to optimize interaction with the bioactive agent at some location of the cells, then changing the direction of the polarizing field one or more times to create the same conditions and reactions at other locations of the cells.
Another object of the invention is to increase the effectiveness of a bioactive agent or agents administered to the body by exposing all of the body, or a selected target region of the body, to a nonuniform, or to a relatively uniform, polarizing static electric and/or static magnetic field with sufficient amplitude (strength) to influence the charge distribution near, on, or within exposed cells so as to increase the receptivity or susceptibility of the cells to interaction with the bioactive agent by increasing the attraction of the agent to locations of the cells and/or by initiating or preventing a metabolic process of the cells in the presence of the agent.
Another object of the invention is to increase the effectiveness of a bioactive agent or agents administered to the body by exposing all of the body, or a selected target region of the body, to a nonuniform, or to a relatively uniform, polarizing static electric and/or static magnetic field of one amplitude (strength) to influence the charge distribution near, on, or within exposed cells to a certain degree, and by then increasing and/or decreasing the amplitude one or more times to influence the charge distribution near, on, or within exposed cells to another degree, so as to increase the receptivity or susceptibility of the cells to interaction with the bioactive agent by increasing attraction of the agent to locations of the cells and/or by initiating or preventing metabolic processes of the cells in the presence of the agent.
It is another object of the invention to increase the effectiveness of a bioactive agent or agents administered to the body by exposing all of the body, or a selected target region of the body, to a nonuniform, or to a relatively uniform, polarizing static electric and/or static magnetic field creating charge gradients near, on, or within exposed cells to increase the receptivity or susceptibility of the cells to interaction with the bioactive agent by increasing the attraction of the agent to locations of the cells and/or by initiating or preventing a metabolic process of the cells in the presence of the agent because of a particular charge level so created at some location on, near, or within the cells.
It is another object of the invention to use any combinations of the methods of the above noted objects to increase the effectiveness of any bioactive agent or agents administered to the body in the presence of a polarizing field.
These objects, as well as other objects, which will become apparent in the following discussion, may be selectively achieved singularly or in any combination, and the invention may be practiced with one or combinations of bioactive agents. The result is a highly desirable increase in action of the bioactive agent, or agents, which can increase their therapeutic potency, even to the point of requiring less bioactive agent if desired. Also, if desired, the increased action of the bioactive agent may be restricted to only certain areas of the body, thus reducing what may be undesired action of the agent or agents in or on other areas of the body. In addition, the increased action of the bioactive agent may result in agents which were formerly only marginally effective becoming effective enough for beneficial use.